FDA Completes Type A Meeting Following CRL for Tabelecleucel in EBV+ R/R Post-Transplant Lymphoproliferative Disease
The FDA and Atara Biotherapeutics completed a Type A meeting to discuss the CRL for tabelecleucel in post-transplant lymphoproliferative disease.
FDA Completes Type A Meeting for Tab-Cel in EBV+ PTLDThe FDA and Atara Biotherapeutics completed a Type A meeting to discuss the CRL issued for the BLA seeking the approval of tab-cel in the management of EBV-positive, relapsed/refractory PTLD.Based on the discussions held in the meeting, PFP intends to submit an updated dataset that includes additional patients and longer-term follow-up from ALLELE, along with supportive data.An additional regulatory update on tab-cel is anticipated in the third quarter of 2026.
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